reporting of incidents jazmp

Submit Demands Online

At the time of reporting on 21 January 2011 the outcome of the event was unspecified Follow-up was received from the regulatory authority on 15 June 2011 Laboratory test performed on 18 November 2010 showed Pertussis IgA 51 IU/ml and Pertussis IgG 307 IU/ml This web page is not intended for reporting adverse drug reactions and other safety information Slovenia Please report the suspected adverse reactions that you notice during drug therapy in accordance with the Rules on the Pharmacovigilance of medicinal products for human use (Official Gazette of the Republic of Slovenia No 57/14 and 27/17) in the way it is published on the website

Quality guidelines

The European Medicines Agency's scientific guidelines on the quality of human medicines help applicants prepare marketing authorisation applications Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality safety and efficacy set out in the Community directives

JAZMP: Safety Notices for Medical Devices - June 2020 The manufacturer of the medical device or the manufacturer's representative must inform both the JAZMP and the users of the medical device in writing of the safety corrective measures and the manufacturer must ensure that all users are properly informed

This web page is not intended for reporting adverse drug reactions and other safety information Slovenia Please report the suspected adverse reactions that you notice during drug therapy in accordance with the Rules on the Pharmacovigilance of medicinal products for human use (Official Gazette of the Republic of Slovenia No 57/14 and 27/17) in the way it is published on the website

At home parents would always want to make sure that their kids are safe Perhaps that should be residential properties are for—to provide safety and convenience But in the event of building cracks and damages homeowners would always want to make sure that

In April 2019 the facility successfully completed a periodic regulatory cGMP inspection by JAZMP Subsequent to the Merger in May 2019 following an extensive evaluation and a technology transfer from the Slovenian facility to the Marina del Rey California location management determined that the Slovenia manufacturing facility was not essential to Armata's business

National competent authorities (human)

The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for human medicines The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not pass though the centralised procedure

Medical device manufacturers or manufacturer's representatives must notify JAZMP in writing within 24 hours of any medical device related incident using form MedPri-VIG-obr02 In case of any doubt regarding the criteria for reporting incidents the medical device manufacturer or manufacturer's authorised representative must notify JAZMP of any medical device-related incident using form

At home parents would always want to make sure that their kids are safe Perhaps that should be residential properties are for—to provide safety and convenience But in the event of building cracks and damages homeowners would always want to make sure that

The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for human medicines The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not pass though the centralised procedure

Since 2015 JAZMP was informed only about four adverse events with breast implants Investigation of one of these incidents is ongoing whereas in the remaining three cases the causal link between the implant and health issues was not confirmed Therefore

The report documents the special measures taken by 30 OECD countries and partners It provides evidence on institutional arrangements and monitoring rules that were introduced for emergency contracting of critical items needed for the current COVID-19 situation and the support provided by the respective ministry or public procurement central body to the contracting authorities especially in

Although incidents implicating falsified medicines have only been systematically recorded after the entry into force of the Directive in January 2013 some incidents of falsification were detected before 2013 either due to their severe public health consequence or because they also

At home parents would always want to make sure that their kids are safe Perhaps that should be residential properties are for—to provide safety and convenience But in the event of building cracks and damages homeowners would always want to make sure that

Comfort Securities

The inspection was focused on follow up on the effectiveness of the CAPA implemented from the last JAZMP inspection and general GMP inspection of the site On 15 November 2017 Divi's Laboratories announced that the US-FDA has lifted/removed import alert 66-40 imposed on the company's Unit-II

člen Article 25 (sporočanje podatkov o obsegu predpisovanja in porabe zdravil) (Reporting data on the amount of medicinal products prescribed and consumed) (1) Izvajalci zdravstvene dejavnosti na zahtevo JAZMP sporočajo podatke o obsegu predpisovanja in

Since 2015 JAZMP was informed only about four adverse events with breast implants Investigation of one of these incidents is ongoing whereas in the remaining three cases the causal link between the implant and health issues was not confirmed Therefore

Reporting of incidents FORMS MedPri-VIG-obr01 Notification on complications incident involving a medical device MEdPri-VIG-obr02 – NEW – Manufacturer Incident Report (MIR 7 2 1) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) (Helptext)

Jazmp si or in case of emergency contact 24-hours available mobile phone number: + 386 41 790 133 Next section of the document provides guidance with examples on reporting of certain specific defect types or suspected counterfeit medicines on the market to JAZMP

člen Article 25 (sporočanje podatkov o obsegu predpisovanja in porabe zdravil) (Reporting data on the amount of medicinal products prescribed and consumed) (1) Izvajalci zdravstvene dejavnosti na zahtevo JAZMP sporočajo podatke o obsegu predpisovanja in

Although incidents implicating falsified medicines have only been systematically recorded after the entry into force of the Directive in January 2013 some incidents of falsification were detected before 2013 either due to their severe public health consequence or because they also

1 ANNUAL REPORT 2013 Krka d d Novo mesto 2 3 Contents INTRODUCTION 3 STATEMENT BY THE PRESIDENT OF THE MANAGEMENT BOARD REPORT OF THE SUPERVISORY BOARD 5 FINANCIAL HIGHLIGHTS OF THE KRKA GROUP'S PERFORMANCE KRKA GROUP BUSINESS MODEL KRKA GROUP ORGANISATION CHART OVERVIEW OF SIGNIFICANT EVENTS AND

Jazmp si GENERAL With an increasing number of medical devices in use or on the market there are also incidents associated with them Incidents with medical devices are managed in medical device vigilance system following the Guidelines on a Medical Devices Vigilance System which for the territory of the Republic of Slovenia are incorporated into the Medical Devices Act (Official Gazette of

JAZMP: Safety Notices for Medical Devices - June 2020 The manufacturer of the medical device or the manufacturer's representative must inform both the JAZMP and the users of the medical device in writing of the safety corrective measures and the manufacturer must ensure that all users are properly informed